NCT05334433

Brief Summary

The aim of this study is to evaluate the effect of needless injection (comfort in ject) on child behavior and its effect on adjacent oral mucosa and soft tissue in children during local anesthesia injection in comparison to the conventional injection technique

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 19, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

September 20, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2023

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

3 months

First QC Date

April 5, 2022

Last Update Submit

September 9, 2023

Conditions

Child Behavior

Outcome Measures

Primary Outcomes (1)

  • Child behavior (Feeling pain during injection) (Binary Yes/No)

    Pain perception during LA injection

    During injection (Immediate) (No follow up)

Study Arms (2)

Local anesthesia injection with the comfort in jet (Needless system)

EXPERIMENTAL

A needle-less injection approach will be used to administer the local anesthetic solution

Procedure: Local anesthesia injection

Local anesthesia injection with needle injection (conventional technique).

ACTIVE COMPARATOR

A conventional aspirating syringe fitted with 27-gauge long needles will be used to administer the local anesthetic solution.

Procedure: Local anesthesia injection

Interventions

Local anesthesia injectionPROCEDURE

Local anesthesia administration

Local anesthesia injection with needle injection (conventional technique).Local anesthesia injection with the comfort in jet (Needless system)

Eligibility Criteria

Age6 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • According to Wright's classification of child behavior, children are classified as cooperative or possibly cooperative.
  • Children who are medically fit.
  • Children who are capable of interacting on a mental level.
  • Children between the ages of 6 to 8.
  • First dental visit.

You may not qualify if:

  • Children who struggle with behavioral control (uncooperative).
  • Children who have a history of allergic reaction to local anesthetic drugs.
  • Parental rejection for participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Cairo University, Cairo, Egypt

Cairo, 11553, Egypt

Location

MeSH Terms

Conditions

Child Behavior

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 5, 2022

First Posted

April 19, 2022

Study Start

September 20, 2022

Primary Completion

December 20, 2022

Study Completion

May 20, 2023

Last Updated

September 13, 2023

Record last verified: 2023-09

Locations

EG(1)